Rising evidentiary standards, pricing pressure and policy changes are redefining what it takes for pharmaceutical products to succeed. Pharmaceutical companies must rethink how R&D decisions are made, ensuring that clinical trial designs reflect the kind of evidence required for access and optimal reimbursement. Unfortunately, in too many companies, clinical development…
While both sides of the U.S. political aisle are focused on bringing down drug prices, they’re missing a critical lever for long-term change: raising the evidentiary bar for what qualifies as clinical value. In late 2025 the FDA signaled a major policy shift in removing barriers to the use of…
The FDA’s recent move to modernize evidence standards marks a turning point in how drug value will be judged, priced and compared globally, with direct consequences for how pharmaceutical companies operate internally. If evidence is becoming the currency of value, pharmaceutical leaders must stop treating it as a downstream exercise…
Clinical research networks continue to play a pivotal role in supporting pipeline development. However, the importance of these networks extends well beyond the conduct of clinical trials. Clinical investigators can support market conditioning, serve as important levers for informing evidence-based clinical pathways/guidelines, and aid in the generation of real-world evidence…
With spiraling cost inflation and lagging quality indicators driving a transition to a value-based system, public and private payers are using sophisticated tools, including health technology assessment (HTA), to evaluate the benefits of the products they buy. In this environment, companies must demonstrate both clinical efficacy and differentiated economic value…
